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		NIH Staff FAQs

[Return to the OER FDAAA home page] (Please note that "grantee" in these FAQs refers to recipients of both grants and cooperative agreements.)

Related NIH Staff FAQs

September 16, 2016 - NIH will be updating FAQs for NIH grantees in accordance with the HHS rule and NIH policy which are effective January 18, 2017. The NIH policy affects all NIH-funded clinical trials. Read the summary.

  A. NIH-Funded Clinical Trials & FDAAA

1. What is FDAAA?

   The Food and Drug Administration Amendments Act of 2007 (FDAAA), Title VIII, expands the National Library of Medicine (NLM) clinical trials registry and results database known as ClinicalTrials.gov and imposes new requirements that apply to certain trials supported by NIH funds, in accordance with the new Final Rule effective January 18, 2017.
2. Which clinical trials are subject to FDAAA?

   Clinical trials considered to be “applicable clinical trials” or ACTs are subject to FDAAA. Applicable clinical trials generally include:

   • Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and
   • Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post market surveillance.
3. What is the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information?

   The new NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information is complementary to the statutory and regulatory reporting requirements of FDAAA and establishes the expectation that all investigators conducting clinical trials funded in whole or in part by the NIH will ensure that these trials are registered and results information is submitted to ClinicalTrials.gov.
4. What studies does NIH consider clinical trials?

   NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. (See NOT-OD-15-015: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html).

   Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

5. What clinical trials need to be registered in clinicaltrials.gov?

   All NIH-funded clinical trials, funded in whole or in part by NIH, including applicable clinical trials (ACTs) subject to FDAAA, need to be registered in ClinicalTrials.gov.
6. What are the effective dates of FDAAA and the NIH Policy?

   FDAAA covers applicable clinical trials (ACTs) that were initiated after 9/27/2007 or were initiated before 9/27/2007 but were ongoing as of 12/26/2007.

   The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information covers all applications for funding (including grants, contracts, and other transactions) submitted on or after January 18, 2017 that request support for the conduct of any clinical trial. The policy does not apply to clinical trials in ongoing, non-competing awards, but will apply if the grantee submits a competing renewal application that includes a new clinical trial.
7. What is the deadline for registering my clinical trial in clinicaltrials.gov?

   The standard timeline for FDAAA and the NIH Policy for registering a clinical trial in clinicaltrials.gov is not later than 21 calendar days after the enrollment of the first participant.
8. When do I need to submit the results of my clinical trial in clinicaltrials.gov?

   The standard timeline for FDAAA and the NIH Policy for submitting results information is not later than one year after the trial’s primary completion date, which is the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated.

  B. Roles and Responsibilities

1. Who determines if a clinical trial supported in part or in whole by an NIH grant (or proposed in an application) is subject to the registration requirement?

   Given that all NIH-supported clinical trials are subject to the NIH Policy, the recipient institution is required to determine whether an NIH-supported clinical trial is also subject to regulatory and statutory requirements of FDAAA. Investigators and institutional officials (e.g., sponsored research office, general counsel, and/or other similar office) are encouraged to work together to determine whether or not an NIH grant is supporting an applicable clinical trial (subject to FDAAA).
2. Who is responsible for meeting requirements to register and report results for clinical trials?

   For applicable clinical trials subject to FDAAA, the responsible party (generally the awardee or investigator) is responsible for registration and results reporting. . For clinical trials that are not subject to FDAAA, the NIH policy states that the awardee or investigator is responsible for meeting registration and results reporting requirements. 
3. I am the PD/PI on an NIH grant, but I am not the responsible party for the clinical trial that the grant supports. If the trial is not in compliance with FDAAA or in adherence with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, may I register or submit results of the trial in ClinicalTrials.gov?

   No. Only the responsible party may register a trial or report results in ClinicalTrials.gov. If you are not the responsible party, you should work with your Authorized Organizational Representative (Signing Official) to identify the responsible party and work with that entity to promote compliance with FDAAA or the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information

  C. Complying with FDAAA and the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information

1. Is compliance with FDAAA and the NIH Policy on the Dissemination of NIH Funded-Clinical Trial Information required?

   Compliance with FDAAA is a legal requirement and a term and condition of the NIH award.

   The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information requires applicants to submit a plan outlining how they will meet the policy’s expectations, that is, how all investigators conducting clinical trials funded in whole or in part by NIH will ensure that these trials are registered at and results submitted to ClinicalTrials.gov. 
2. Upon receipt of the award, an awardee will be obligated to adhere to their plan through the terms and conditions of the award. Where can I find information about how to comply with FDAAA?

   Detailed steps for compliance with FDAAA for NIH grantees can be found at https://grants.nih.gov/ClinicalTrials_fdaaa/steps.htm.
3. What needs to be included in NIH competing (new and renewal) applications and progress reports to provide certification of compliance with FDAAA or the NIH Policy?

   OER’s website “What NIH Grantees Need to Know about ClinicalTrials.gov and FDAAA” provides a full description of what needs to be included in NIH competing renewal applications and Research Performance Progress Reports (RPPR) to certify compliance with FDAAA. See Certifying compliance with FDAAA in applications and progress reports for additional details.

   NIH will require the applicant to submit the plan outlining how they will meet the NIH Policy’s expectations prior to a new competing award.  Recipients will be required to certify compliance with registration and results submission in each RPPR.
4. Is certification of compliance with FDAAA required for grants providing statistical, laboratory, administrative, or other support functions for applicable clinical trials?

   Yes. Any grantee receiving NIH funds to provide support for an applicable clinical trial is required to certify compliance with FDAAA. Even if the recipient is not the responsible party, the recipient must certify compliance with FDAAA.
5. Does the NIH Policy apply to clinical trials that use NIH-supported infrastructure but does not receive NIH funds to support its conduct?

   No. The NIH Policy does not apply to clinical trials that use NIH-supported infrastructure but does not receive NIH funds to support its conduct.

  D. Results and Reporting

1. When must clinical trial results information be submitted?

   The standard timeline for FDAAA and the NIH Policy for submitting results information is not later than one year after the trial’s primary completion date, which is the date that the final subject was examined, or received an intervention, for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated.
2. What data elements are required for registration and results reporting to be in compliance with FDAAA and the NIH Policy?

   Information on the data elements required by FDAAA and the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information for registration and results reporting may be found on the ClinicalTrials.gov PRS (Protocol Registration System) Information web site.

   • Data elements for protocol registration: http://prsinfo.clinicaltrials.gov/definitions.html
   • Data elements for results reporting: http://prsinfo.clinicaltrials.gov/results_definitions.html
3. Is the information submitted to ClinicalTrials.gov subject to review?

   Yes; ClinicalTrials.gov reviews protocol and results information for apparent validity, meaningful entries, logic and internal consistency, and formatting. The review focuses on assessing whether the entered data could be understood by a reader of the medical literature who is not already familiar with the study. For further information, please see: ClinicalTrials.gov Review of Results Submissions.

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